The US FDA’s regulation of ‘off-label communications’ (communications about the use of FDA-approved pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration) can be complex and confusing, especially for Irish and Northern Irish life sciences companies marketing/distributing their product in the US. Recent FDA actions have muddied the waters a bit more. Without clear guidance from the FDA , life sciences companies are struggling to decide how best to approach off-label communications, if at all. Continue reading →

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Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and has several updates of interest for Irish and Northern Ireland life sciences companies operating, or looking to operate, in the US: (i) additional discussion of the Amarinoff-label promotion case; (ii) guidance for data-driven medical device companies on implementing effective data security and privacy measures; and (iii) potential changes that could streamline 510(k) medical device reviews at FDA. If you have questions or comments about the newsletter, please contact me or the author(s) of the articles in question.

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Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has approved of certain other uses for such drug/device)–and the FDA’s restrictions on the same. In a recent case (Amarin Pharma, Inc. v. United States Food and Drug Administration, August 5, 2015), the 2nd U.S. Circuit Court of Appeals held that the FDA cannot prosecute companies and their representatives under the Federal Food, Drug, and Cosmetic Act for truthful, non-misleading discussion, even if about off-label uses for a drug/device. Further, the court enjoined FDA in the case from considering the off-label communications to be evidence of misbranding. The decision makes clear that false or misleading statements are not protected speech. This decision is binding only within the jurisdiction of the Federal Second Circuit Court of Appeals: Federal courts in New York, Connecticut, and Vermont. However, the decision is clearly a win for industry to communicate proactively truthful and non-misleading information about clinical trial results. My colleagues Alan Minsk and Bill Kitchens have written an excellent client alert on this case and its impact, available here. Despite the questionable use of a song title from the band Queen, the update is well worth the time for any Irish or NI life sciences company operating in, or looking to expand to, the U.S.

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AGG produces a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from our Washington, DC office. The June 2015 update is located here. Two items should be of particular interest to Irish and Northern Irish companies whose products fall under US FDA regulation: Continue reading →

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A few weeks ago, I posted a primer on government contracts. Two of my colleagues, Tenley Carp and Jeff Jacobovitz have published a primer for non-US life sciences companies on selling to the US government. That primer is available here and is worth the read for Irish and NI companies.

Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of individual prosecution under the FDCA for company violations of that statute. AGG partner Alan Minsk and associate Alex Foster have written an update that is new to AGG’s Knowledge Center. Continue reading →

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About Mike

Michael Burke is a partner in the Corporate Practice of Arnall Golden Gregory, LLP, in the Washington, DC office. He provides creative, effective, efficient, and 'business-sensible' legal advice so companies of all sizes, including emerging growth companies, can turn legal challenges into business opportunities. He has a specific focus on advising Irish and Northern Irish companies on doing business in the United States.

He is a past chair of the 23,000-member American Bar Association Section of International Law, and was the youngest person elected chair of that Section. Mr. Burke has an AV Preeminent™ Rating from Martindale-Hubbell; was named to Washington DC Super Lawyers by Thomson Reuters; was awarded the Business & Finance Magazine Global 100 Irish Business Leaders 2014; and was named to the Irish Legal 100 in 2012 and 2013.

His father's family is from Cahir, Tipperary, and his mother's family is from Castlerea, Roscommon.